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The Basis for OncoVAX®

• About Vaccinogen
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• What is OncoVAX®?
• The Basis for OncoVAX®
• Driving Principles

The basis for Vaccinogen’s OncoVAX® vaccine is that there are distinct tumor antigens in each patient’s tumor cells that are either absent or in much lower concentrations on normal cells. These tumor antigens may also be different from other patients’. This makes cancer a far more heterogeneous disease at the molecular level than pathology would have you believe at the cellular level. Active specific immunotherapy is a patient-specific strategy to induce a functional anti-tumor immune response against the tumor cells and the component tumor antigens. This immune reaction unleashes cytotoxic white blood cells, called T-cells, capable of destroying the target tumor cells.

The basis for Vaccinogen’s OncoVAX® vaccine is that there are distinct tumor antigens in each patient’s tumor cells that are either absent or in much lower concentrations on normal cells.

There are other strategies to achieve immunotherapy for cancer. Most of these approaches are more general in their approach; many of these have failed. The reason for this is that, while they use tumor proteins or components, these had not been validated to be functional immunogens or they lacked important immunogens not yet identified. In essence, they failed because they operated on the assumption that cancer is homogeneous. Using tumor cells derived from each patient obviates the problem of cancer heterogeneity. 

Fundamentally, OncoVAX® therapy activates the patient’s defenses against the existing tumor specific antigens by enhancing the immunogenicity of autologous tumor cells. These patient specific tumor cells are irradiated and combined with the immunomodulating effects of a strong adjuvant, TICE BCG. This strain of bacteria activates the innate immunity to promote antigen processing, antigen presentation and development of cytotoxic T-cell response.

In Stage II colon cancer, a disease in which surgery is curative in approximately 70% of the patients, chemotherapy has not shown a significant additional benefit. Thus, Stage II colon cancer, which is increasing in incidence due to improved diagnostic procedures, can be classified as an unmet medical need. In the first clinical trial for OncoVAX®, three induction vaccinations with a six-month booster was used. This achieved a significant improvement in the relevant parameter of disease free survival.

While there is justification for the basis of OncoVAX® and its application in minimal residual disease such as Stage II colon cancer, the requisite logistics of patient specific therapy and the pharmaceutical manufacturing requirements of a vaccine using live, metabolically active tumor cells have been daunting. However, working closely with the Food and Drug Administration, the firm has been able to consistently achieve a sterile, potent and well characterized drug product for use in carcinoma therapy. Vaccinogen’s challenge now is the final translational development of this product and worldwide commercialization.